Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series
BMJ Open, vol. 12, pp. e055324
Abstract
INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice. METHODS AND ANALYSIS: Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients' perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals' perspective on the implementation process. ETHICS AND DISSEMINATION: The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM. TRIAL REGISTRATION NUMBER: NL8374, NL8375 and NL8376.
Authors 17
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Mariska Q.N. Hackert corresponding
Affiliation as printed
Santeon Hospital Group, Utrecht, The Netherlands
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Santeon (Netherlands) · University of Twente
Affiliation as printed
Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands
Santeon Hospital Group, Utrecht, The Netherlands
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Maasstad Ziekenhuis · Santeon (Netherlands)
Affiliation as printed
Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands
Santeon Hospital Group, Utrecht, The Netherlands
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Affiliation as printed
Neurology, OLVG, Amsterdam, The Netherlands
Santeon Hospital Group, Utrecht, The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
Radboud Institute for Health Sciences, Health Evidence, section Biostatistics, Radboud University Medical Centre, Nijmegen, The Netherlands
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Netherlands Comprehensive Cancer Organisation · University of Twente
Affiliation as printed
Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands
Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands
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Affiliation as printed
Psychology, Health and Technology, University of Twente, Enschede, The Netherlands
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Canisius-Wilhelmina Ziekenhuis
Affiliation as printed
Surgical Oncology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
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Affiliation as printed
Surgical Oncology, Catharina Hospital, Eindhoven, The Netherlands
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Affiliation as printed
Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands
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Leiden University · Leiden University Medical Center · St. Antonius Ziekenhuis
Affiliation as printed
Internal Medicine, Leiden University Medical Centre, Leiden, The Netherlands
Internal Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · St. Antonius Ziekenhuis · Radboud Institute for Health Sciences
Affiliation as printed
Radboud Institute for Health Sciences, Scientific Centre for Quality of Healthcare (IQ Healthcare), Radboud University Medical Centre, Nijmegen, The Netherlands
Value-Based Health Care, St. Antonius Hospital, Nieuwegein, The Netherlands
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Amsterdam UMC Location University of Amsterdam · OLVG · Amsterdam University Medical Centers
Affiliation as printed
Neurology, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
Neurology, OLVG, Amsterdam, The Netherlands
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Affiliation as printed
Neurology, OLVG, Amsterdam, The Netherlands
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Affiliation as printed
Value-Based Health Care, St. Antonius Hospital, Nieuwegein, The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
Radboud Institute for Health Sciences, Rehabilitation, Radboud University Medical Centre, Nijmegen, The Netherlands
Radboud Institute for Health Sciences, Scientific Centre for Quality of Healthcare (IQ Healthcare), Radboud University Medical Centre, Nijmegen, The Netherlands
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Affiliation as printed
Santeon Hospital Group, Utrecht, The Netherlands
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